MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/28/2024, it was reported by a sales representative via email that pieces from an ar- 8400obe oval burr came off into the patient.The surgeon was able to remove the broken fragments.The surgeon reported that while maneuvering the burr, a click could be felt.The burr did not come in contact with the scope or any other devices.This was discovered during a procedure on (b)(6) 2024.Additional information provided 3/4/24: the procedure performed was an ankle arthroscopic procedure.The case was completed by opening a new burr.No case delay.No additional anesthesia.No negative effects to the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection: after removing the outer tube, abrasion marks were found around its inner diameter.The inner tube had abrasion lines at the tip and rust marks around the window.Functional testing was not performed due to the abrasion marks on the device.The most likely cause(s) for the reported failure is prying/leveraging the device against bone or another instrument.Per dfu-0215-4 at revision 0.Section f.Precautions.5.Excessive "side-loading" on the device during use does not improve cutting performance and, in extreme cases, will cause irreversible damage to the device.

• Brand Name: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• Common Device Name: BURR,SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18870170
• Report Number: 1220246-2024-01392
• Device Sequence Number: 12732408
• Product Code: GFF
• UDI-Device Identifier: 00888867043602
• UDI-Public: 00888867043602
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400OBE
• Device Lot Number: 11204932
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown